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SEC Company Response from ABBOTT LABORATORIES (ABT) — May 6, 2010

ABBOTT LABORATORIES
Date: May 6, 2010 · CIK: 0000001800 · Accession: 0001104659-10-026305

AI Filing Summary & Sentiment

File numbers found in text: 001-02189

Date
April 22, 2010
Author
Thomas C. Freyman
Form
CORRESP
Company
ABBOTT LABORATORIES

Letter

United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4720 F Street, NE Washington, D.C. 20549 RE: File Number 001-02189

Dear Mr. Rosenberg:

In reply to your letter of April 22, 2010, we have enclosed our response to comments 1 and 2 in the attachment to this letter.

As per your request, Abbott acknowledges that we are responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and Abbott may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.

Abbott will be submitting its response to comments 3 and 4 separately.

Very
truly yours,
/s/
Thomas C. Freyman

Show Raw Text
CORRESP
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filename1.htm

May 6,
2010

Mr. James
Rosenberg

Senior
Assistant Chief Accountant

United
States Securities and Exchange Commission

Division
of Corporation Finance

Mail
Stop 4720

100
F Street, NE

Washington,
D.C.  20549

RE:  File Number 001-02189

Dear
Mr. Rosenberg:

In
reply to your letter of April 22, 2010, we have enclosed our response to
comments 1 and 2 in the attachment to this letter.

As
per your request, Abbott acknowledges that we are responsible for the adequacy
and accuracy of the disclosure in the filing; staff comments or changes to
disclosure in response to staff comments do not foreclose the Commission from
taking any action with respect to the filing; and Abbott may not assert staff
comments as a defense in any proceeding initiated by the Commission or any
person under the federal securities laws of the United States.

Abbott
will be submitting its response to comments 3 and 4 separately.

Very
truly yours,

  /s/
  Thomas C. Freyman

  Thomas
  C. Freyman

  Executive
  Vice President, Finance

  and
  Chief Financial Officer

  Enclosure

Abbott
Laboratories

Form 10-K
for the fiscal year ended December 31, 2009

Filed February 19,
2010

File No. 001-02189

General

1.                                      We have
not yet reviewed the Part III information that is included in your
definitive proxy statement.  We may have
further comments after reviewing that information and we will not be able to
clear our review of our filing until we have the opportunity to resolve any
resulting comments.

Response:

We
acknowledge that you may have further comments after reviewing the Part III
information in our proxy statement.

Item
7.  Management’s Discussion and Analysis
of Financial Condition and Results of Operations

Financial
Review, page 26

2.                                      You
incurred $2.7 billion, $2.7 billion and 2.5 billion on research and development
activities, excluding acquired in-process research and development, in 2009,
2008 and 2007, respectively, representing 9%, 9% and 10% of net sales,
respectively, and 38%, 46% and 56% of pretax earnings from continuing operations,
respectively, for these years.  However,
your disclosures about your research and development pipeline appear to be
limited to general statements regarding the therapeutic areas you are focusing
on and that you have dedicated, and plan to continue to dedicate, substantial
resources to maximizing the worldwide potential of HUMIRA.  Please expand your disclosure by referring to
the Division of Corporation Finance “Current Issues and Rulemaking Projects
Quarterly Update” under section VIII — Industry Specific Issues — Accounting
and Disclosure by Companies Engaged in Research and Development
Activities.  You can find it at the
following website address:
http://www.sec.gov/divisions/corpfin/cfcrq032001.htm#secviii.

Please disclose the following information for each of your major
research and development projects:

a.              The
nature, objective, and current status of the project and the extent that its
success relies on parties other than you;

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b.              The
costs incurred during each period presented and to date on the project;

c.               The
nature, timing and estimated costs of the efforts necessary to complete the
project;

d.              The
anticipated completion dates;

e.               The
risks and uncertainties associated with completing development on schedule, and
the consequences to operations, financial position and liquidity if the project
is not completed timely; and finally

f.                 The
period in which material net cash inflows from significant projects are
expected to commence.

Regarding b., if you do not maintain any research and development costs
by project disclose that fact and explain why management does not maintain and
evaluate research and development costs by project.  Provide other quantitative or qualitative
disclosure that indicates the amount of the company’s resources being used on
the project.

Regarding c., d., and f., disclose the amount or range of estimated
costs and timing to complete the phase in process and each future phase.  To the extent that information is not
estimable, disclose those facts and circumstances indicating the uncertainties
that preclude you from making a reasonable estimate.

Response:

Information
on the nature, objective, and status of R&D projects is regularly
communicated in Abbott’s quarterly earnings releases, other press releases,
Investor Relations presentations and on our corporate website.  While we believe that our disclosures related
to R&D activities are adequate, we propose to include additional disclosure
in the format below in future Form 10-K filings.

Abbott
currently has numerous pharmaceutical and medical device products in
development.  The significant areas of
therapeutic focus include the following:

Pharmaceutical
Products

Immunology
— Projects are ongoing to identify new mechanisms with the potential to treat
an array of immune-mediated diseases.
Projects include early stage work in oral DMARD therapies and a number
of biologic candidates, including ABT-874, an anti-IL 12/23 for psoriasis which
is currently in Phase III development and on track for a regulatory submission
in the summer of 2010.

HUMIRA
— Phase III trials are ongoing for additional indications including ulcerative
colitis in Japan, ulcerative colitis in the U.S. and the European Union (EU),
and peripheral and axial spondyloarthritis
in the U.S. and EU.

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Neuroscience
— Abbott is focused on the development of compounds that target receptors in
the brain that help regulate mood, memory and other neurological functions to address
conditions such as Alzheimer’s disease, schizophrenia and multiple
sclerosis.  ABT-126 and ABT-288, two
compounds directed toward the treatment of Alzheimer’s disease, moved forward
into Phase II studies in late 2009.
Daclizumab, a biologic acquired through the recent acquisition of Facet
Biotech Corporation, is on track to enter Phase III clinical trials in the
second quarter of 2010.

Oncology
— Abbott is focused on the development of targeted, less-toxic treatments that
inhibit tumor growth and improve response to common cancer therapies.  Compounds continuing to move through
development include:

·                  ABT-869, a
multi-targeted kinase inhibitor, for which a Phase III trial in hepatocellular
carcinoma was recently initiated and Phase II studies for other cancer types
are ongoing.

·                  ABT-263, a
Bcl-2 family protein antagonist, currently in Phase II development for chronic
lymphoid leukemia.

·                  ABT-888, a
PARP-inhibitor, currently under evaluation for a number of cancer types,
including metastatic melanoma.

·                  Additional
compounds in early and mid-stage development, including two compounds from the
recent Facet Biotech acquisition.

Hepatitis
C — Abbott’s hepatitis C development programs include a partnership with Enanta
Pharmaceuticals to discover protease inhibitors as well as internal programs
focused on additional viral targets.  In
the first quarter of 2010, Abbott initiated Phase II clinical trials to
evaluate 3 of Abbott’s hepatitis C antiviral agents, including the
investigational protease inhibitor ABT-450, part of the Enanta collaboration,
and polymerase inhibitors ABT-333 and ABT-072, currently being developed
exclusively by Abbott.

In
addition, work is continuing on numerous early-stage programs, including the
biologic acquired from Pangenetics for chronic pain in late 2009, a cMet
antibody for cancer in partnership with Pierre Fabre SA, and other programs
across all of Abbott’s therapeutic areas of focus.

Medical Devices

Vascular
— Ongoing projects in the pipeline include:

·                  Xience Nano, a
version of Xience V for small vessels, currently in clinical trials in the U.S.

·                  Xience PRIME,
the next-generation drug-eluting stent (DES) based on Xience V attributes.  Ongoing clinical trials for Xience PRIME in
the U.S. are evaluating a range of stent sizes, including small vessel and long
lengths.

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·                  “Thinman” DES,
an ultra thin DES, which is designed to improve clinical outcomes by reducing
vessel injury upon deployment, enabling faster healing and improving
deliverability in complex anatomy.

·                  Bioabsorbable stents that are gradually
reabsorbed into the vessel wall. Abbott recently released three-year data from
its bioabsorbable clinical trial, which showed efficacy and safety results
consistent with the two-year data.  In
late 2009 Abbott also initiated the ABSORB EXTEND clinical trial which will
enroll up to 1,000 patients with more complex coronary artery disease.

·                  MitraClip
device for the treatment of mitral regurgitation — In March 2010 Abbott
announced data from the EVEREST II (Endovascular Valve Edge-to Edge REpair
STudy) trial demonstrating that the MitraClip system met both its primary
safety and effectiveness endpoints.
Abbott submitted the final PMA module for FDA review in March 2010.

·                  Core product projects, including the
MULTI-LINK 8 bare metal stent, next-generation frontline and high-pressure
balloons, and new guidewires are continuing to move forward.

Medical Optics

Synchrony,
a next-generation accommodating intraocular lens designed to mimic the eye’s
natural ability to change focus and deliver improved vision at all distances
for patients following cataract surgery, is currently under FDA review.

Molecular Diagnostics

Abbott
continues to partner with other pharmaceutical companies to develop molecular
tests to screen for non-small cell lung cancer and to aid in selecting patients
who may benefit from a skin cancer treatment.

Diagnostics

Diagnostic
tests in development include:

·                  An ARCHITECT immunoassay that can help in the
assessment of ovarian cancer.  Abbott has
submitted the test to the FDA for 510(k) clearance.

·                  An ARCHITECT HIV Ag/Ab combo assay to detect
acute and chronic HIV infection earlier than currently approved test.  Abbott has submitted a Pre-market Approval
(PMA) application to the FDA.

·                  A blood-screening test for Chagas disease for
Abbott’s PRISM instrument.  Already
available internationally, the test is in development in the U.S.

·                  Next-generation immunology and hematology
platforms.

With
respect to the costs incurred on each project and the estimated costs of the
efforts necessary to complete the project, we believe that it would not be
practicable to provide such detailed information and that providing cost
information by project would be detrimental to Abbott’s competitive position
and therefore, to our shareholders.
Although we will provide additional disclosure on the status of
significant projects as

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proposed
above, we do not believe it would be appropriate to make cost information by
project public for competitive reasons.

Furthermore,
in most cases, cost estimates evolve and are developed in greater detail as
each phase of research success is achieved.
A summary of only predictable costs used to determine that the research
should proceed would be of limited value, if not misleading, to a reader.  Likewise, a projection of total possible
costs for each project would also be unreliable as research project spending
advances at different rates depending on success, competitive factors,
technological advances and the potential pricing available in global
markets.  We manage our portfolio of
projects and spend on enterprise and segment bases and allocate resources on an
ongoing basis consistent with targets that deliver return to our
shareholders.  This is an iterative
process and can result in frequent changes to the timing and amount of spend on
individual projects.  Total R&D spend
is disclosed and we also indicate that the majority are concentrated on
pharmaceutical products.

With
respect to the other information requested in the Staff’s letter, the nature of
the efforts necessary to complete a project is indicated by the project’s
current development phase as described in the disclosure above.  The Staff’s letter also requests information
regarding timing, anticipated completion dates, risks and uncertainties, and
the period in which net cash inflows are expected to commence.  As discussed in the Risk Factors in our Form 10-K,
a high rate of failure is inherent in the research and development of new
pharmaceutical and medical device products and technologies.  Failure can occur at any point in the
process, including after significant funds have been invested.  The risk of failure, potential scientific and
regulatory delays, and the unknown future impact of competitors’ innovations
make it extremely difficult, and perhaps unreliable, to provide such
information on completion and launch dates and other timing.  Given that we mitigate risk by investing in a
diversified set of R&D projects, it is unlikely that a delay in a
particular project or multiple projects would have a material impact on Abbott’s
operations.  If the latter was expected
to have a material impact, we would make the appropriate disclosures.  In future Form 10-K filings, we will
either state that there have not been delays in Abbott’s research and
development activities that are expected to have a material impact on
operations or we will disclose information on the significant delay.

In
summary, we believe that the additional disclosures proposed above on the
nature and status of projects, disclosures as needed on the impact of material
delays, and the current disclosures on R&D spend and activity achieve the
objective of the Division of Corporation Finance’s “Current Issues and
Rulemaking Projects Quarterly Update” to enhance an investor’s understanding of
the company’s use and expected use of resources in R&D activities.

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